Investigational Device Exemption (IDE) Submission Workshop
February 24, 2010 — The Westin Casuarina Hotel, Las Vegas, NV
OverviewMTLI offers this one-day interactive workshop to lead attendees through the regulatory and practical guidelines governing when an IDE is required, how to compile an effective IDE applications, the rules governing clinical studies and human subject protection, Institutional Review Boards, types of pre-IDE meetings and communications, early/expanded access, foreign studies and export, and reimbursement for investigational devices.
SpeakersLynn Henley, Public Health Analyst, FDA/CDRH
Anthony Blank, VP Cardiovascular Regulatory Affairs, Boston Scientific
Michael Morton, Senior Director, Regulatory Affairs, Medtronic
Linda Godfrey, Chief, Program Enforcement Branch A, Division of Bioresearch Monitoring, FDA/CDRH
Hotel & Meeting Logistics
The Westin Casurina Hotel
160 East Flamingo Drive
Las Vegas, NV 89109
A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $129. Please make your reservations by contacting the hotel and identifying yourself as a member of the Advanced Medical Technology Association room block or by clicking here. This rate will be available until February 5, 2010. Room and rates are subject to availability after this date. Please make your reservations early as the block will fill up quickly.
Please contact email@example.com for Group Discounts (Discount does not apply to AdvaMed Accel, Government, or Non-Profit Organizations)